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Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation

NCT07159737 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-12-30

No results posted yet for this study

Summary

The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart. The most critical narrowing occurs in the left main coronary artery (LMCA), which supplies blood to over two-thirds of the heart muscle. Treating this narrowing is essential to prevent heart attacks or death. The LMCA divides into two branches, known as a bifurcation, both of which require treatment if narrowed.

Currently, narrowing in both branches-the left anterior descending artery (LAD) and the left circumflex artery (LCx)-is treated with a two-stent strategy, where metallic stents are placed in each branch to keep the arteries open. However, this approach is prone to re-narrowing, particularly at the origin of the LCx. A new procedure, called the hybrid strategy, offers an alternative. It involves placing one stent in the LMCA and LAD while inflating a special balloon in the LCX. This balloon, known as a drug-coated balloon, releases a chemical that reduces narrowing over time without needing a stent. At present, there is uncertainty which strategy is better. This study will assess whether the hybrid strategy is more effective than the two-stent strategy in preventing death, heart attacks, and re-narrowing of the arteries.

Participants will have an equal chance of receiving either the two-stent or hybrid strategy and will only join the study if their doctor is unsure which method is best. To minimise the burden on participants, all study procedures and follow-ups will be integrated into standard routine care.

The results of this study have the potential to offer a new, safer treatment that could save the lives of millions of people with this condition.

Conditions

  • Unprotected Left Main Coronary Artery Disease

Interventions

PROCEDURE

Two-stent strategy

DES from LMCA to LAD and DES to LCx using a recognised bifurcation technique such as double kissing crush (DK crush), Culotte, T-stenting or T and small protrusion (TAP).

PROCEDURE

Hybrid Strategy

DES from LMCA to LAD and DCB to LCx. No LCx DES unless bail-out needed.

Sponsors & Collaborators

  • Clinical Research Malaysia

    collaborator UNKNOWN

  • Hospital Sultanah Bahiyah

    lead OTHER_GOV

Principal Investigators

  • Dharmaraj Karthikesan, M.D, MSc (Oxon) · Hospital Sultanah Bahiyah, Alor Setar, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-01
Completion
2030-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159737 on ClinicalTrials.gov